TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
1. K211960 Agile Esophageal OTW Stent System
2. K233837 Agile Esophageal Stent System
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
1. K211960 Agile Esophageal OTW Stent System
2. K233837 Agile Esophageal Stent System
M.I. TECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
M.I.TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAEWOONG MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TAEWOONG MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TAEWOONG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THORACENT, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation, Positioning or Separation Problem	196	196
Migration	141	141
Activation Failure	134	134
Activation Problem	72	72
Detachment of Device or Device Component	64	64
Adverse Event Without Identified Device or Use Problem	56	56
Material Deformation	52	52
Improper or Incorrect Procedure or Method	51	51
Use of Device Problem	51	51
Positioning Problem	50	50
Break	46	46
Positioning Failure	38	38
Off-Label Use	34	34
Difficult to Remove	31	31
Material Integrity Problem	28	28
Failure to Advance	25	25
Material Twisted/Bent	22	22
Physical Resistance/Sticking	16	16
Appropriate Term/Code Not Available	11	11
Fracture	11	11
Difficult or Delayed Positioning	10	10
Insufficient Information	9	9
Premature Activation	8	8
Device Stenosis	8	8
Obstruction of Flow	8	8
Difficult to Advance	7	7
Human-Device Interface Problem	7	7
Migration or Expulsion of Device	7	7
Material Perforation	5	5
Structural Problem	4	4
Device-Device Incompatibility	3	3
Separation Problem	3	3
Material Separation	3	3
Unraveled Material	3	3
Unsealed Device Packaging	3	3
Device Markings/Labelling Problem	3	3
Misassembled	2	2
Packaging Problem	2	2
Difficult to Insert	2	2
Entrapment of Device	2	2
No Apparent Adverse Event	2	2
Component Misassembled	2	2
Wrong Label	2	2
Deformation Due to Compressive Stress	2	2
Difficult or Delayed Activation	1	1
Dent in Material	1	1
Reflux within Device	1	1
Malposition of Device	1	1
Defective Component	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	442	442
No Consequences Or Impact To Patient	103	103
Obstruction/Occlusion	36	36
Dysphagia/ Odynophagia	32	32
Hemorrhage/Bleeding	19	19
No Known Impact Or Consequence To Patient	18	18
Insufficient Information	18	18
Perforation	15	15
No Code Available	14	14
Foreign Body In Patient	13	13
Pain	12	12
Vomiting	10	10
Discomfort	10	10
Erosion	9	9
Dysphasia	7	7
Fistula	7	7
Nausea	7	7
Abdominal Pain	6	6
Pneumonia	6	6
Gastrointestinal Hemorrhage	5	5
Ulcer	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Aspiration/Inhalation	4	4
Cough	4	4
Failure of Implant	3	3
Unspecified Tissue Injury	3	3
Decreased Appetite	2	2
Airway Obstruction	2	2
Dyspnea	2	2
Chest Pain	2	2
Fever	2	2
Peritonitis	2	2
Laceration(s) of Esophagus	2	2
Bowel Perforation	2	2
Perforation of Esophagus	2	2
Respiratory Tract Infection	1	1
No Patient Involvement	1	1
Retroperitoneal Hemorrhage	1	1
Laceration(s)	1	1
Hematemesis	1	1
Abscess	1	1
Cardiomyopathy	1	1
Gastrointestinal Regurgitation	1	1
Shock	1	1
Tachycardia	1	1
Stenosis	1	1
Anemia	1	1
No Information	1	1
Feeding Problem	1	1
Skin Tears	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Sep-26-2024
2	Taewoong Medical Co., Ltd.	II	Feb-14-2020